CLINICAL TRIAL METHODS IN NEUROLOGY REQUEST FOR INFORMATION (RFI): NS 04-015
RELEASE DATE: August 19, 2004
NOTICE: NOT-NS-04-015
National Institute of Neurological Disorders and Stroke (NINDS)
(http://www.ninds.nih.gov/)
The National Institute of Neurological Disorders and Stroke (NINDS) is
considering issuing a contract to develop a course of intensive
training in clinical trial methodology for neurology research. NINDS
is attempting to identify sources with experience and expertise to
develop and coordinate the scientific design and implementation of
such training.
Background
The proposed idea is for development and implementation of a short
course in clinical trial methodology targeted to junior
neurology/neurosurgery faculty and fellows. Good design and conduct
of clinical trials can provide definitive answers about the
effectiveness of new therapeutic approaches. This can lead to
promising avenues of research that are based on sound basic scientific
work and lead to the introduction of new treatments into the general
practice of neurology and neurosurgery. The field of neurology
clinical trials is still fairly young and there is a need for more
medically-trained researchers with appropriate methodological
training. Currently, training in clinical research methodology that
is typically provided by undergraduate and post-graduate medical
education programs and fellowships is not adequate for developing
future leaders in neurology clinical trials. The proposed course is
intended to provide the essential basics that will help the trainees
make the transition from an interesting research question to a well-
planned research protocol.
Similar courses in other disciplines (e.g., oncology, cardiovascular
disease) often incorporate lectures, panel discussions, and working
sessions over an intensive training period of 1 to 2 weeks. The
course agenda for this program is intended to focus on general as well
as neurology-specific concepts in clinical trials design and conduct
and to provide students with hands-on experience in developing a
clinical trials protocol. Neurology and neurosurgical clinical
fellows and junior faculty will be invited to apply to attend the
course. To be most effective, we expect the training course to be
conducted at least annually. Evaluation of course quality and impact
will be a significant component of the proposed initiative, with the
results to be incorporated into subsequent years’ programs and
curricula. We also want to stress the importance of methodology and
training in minority populations and investigators.
It is anticipated that this course will yield a group of talented,
dedicated neurology researchers who will consequently be in a position
to obtain funding for their own high quality clinical research. If
the program is successful, it is anticipated that trainees will return
to their academic departments where they will take a prominent role in
advancing local research priorities in neurology.
Goals of the Contract
The purpose of such a “Clinical Trial Methods in Neurology” course is
to increase the reliability and effectiveness of clinical trials by:
introducing clinical fellows and junior faculty in any neurology or
neurosurgical subspecialty to the principles of good clinical trial
design; exposing early career clinical scientists to the full spectrum
of challenges in clinical research; and developing a cadre of well-
trained, experienced clinical researchers whose expertise will foster
better clinical trials design and thereby hasten the introduction of
improved regimens for therapy and prevention of neurological disorders
into everyday medical practice and patient care.
Specific goals of the contract are:
1. To develop scientific content, curriculum, and format of the
training program.
2. To organize and conduct the training program, including
recruitment and selection of faculty and participants.
3. To conduct formal evaluation of the training program.
Information Requested
Information in the following areas will aid in the design of the
proposed solicitation. We ask that interested organizations identify
critical criteria to be included in the solicitation. The information
supplied in response to this request need not be limited to these
areas.
o General scientific approach to identifying content and developing
and implementing the training program;
o General scientific approach to on-going evaluation of the training
program;
o Overall estimation of the number of personnel required and specific
expertise needed, with approximate level of effort required for each;
o Availability of technology;
o Project timeline;
o Your organization’s capability as it relates to this project.
This Request for Information (RFI) is for information and planning
purposes only and shall not be construed as a solicitation or as an
obligation on the part of the Government. The Government does not
intend to award a contract on the basis of responses nor otherwise pay
for the preparation of any information submitted or the Government’s
use of such information. Acknowledgement of receipt of responses will
not be made, nor will respondents be notified of the Government’s
evaluation of the information received. However, should such a
requirement materialize, no basis for claims against the Government
shall arise as a result of a response to this request for information
or the Government’s use of such information as either part of our
evaluation process or in developing specifications for any subsequent
requirement. Responses will be held in a confidential manner. Any
proprietary information should be so marked.
All respondents are asked to indicate the type and size of your
business organization, e.g., Large Business, Small Business, Veteran-
owned Small Business, Service-disabled Veteran-Owned Small Business,
Hubzone Small Business, Small Disadvantaged Business, Women-Owned
Business, 8(a), Historically Black College or University/Minority
Institution (HBCU/MI), educational institution, profit/non-profit
hospital, or other nonprofit organization.
Responses should be identified with NINDS RFI No. 04-015 and are due
by September 9, 2004. Please submit four (4) copies of your response
to:
Ida Lirette
Contract Specialist
or
Laurie Leonard
Contracting Officer
Contracts Management Branch
National Institute of Neurological Disorders and Stroke
NIH
6001 Executive Boulevard, Room 3287 MSC 9531
Bethesda, Maryland 20892-9531.
(for FedEx or courier, use: Rockville, MD 20852)
Phone number: (301) 496-1813
Fax number: (301) 402-4225
E-mail responses, sent to il26v@nih.gov, will also be accepted.